Indications and uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
adults and children 12 years of age and over: take one 180 mg tablet with water every once a day; do not take more than 1 tablet in 24 hours children under 12 years of age: do not use adults 65 years of age and older: ask a doctor consumers with kidney disease: ask a doctor
safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn. store between 20° and 25°C (68° and 77°F) protect from excessive moisture
Fexofenadine HCl USP, 180 mg
Antihistamine
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Get emergency help immediately if you have hives along with any of the following symptoms:
trouble swallowing dizziness or loss of consciousness
swelling of tongue swelling in or around mouth
trouble speaking wheezing or problems breathing
drooling
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later
If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
to prevent hives from any known cause such as:
foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the
cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives,
see your doctor for a medical exam. Your doctor may be able to help you find a cause.
if you have ever had an allergic reaction to this product or any of its ingredients
kidney disease. Your doctor should determine if you need a different dose.
hives that are an unusual color, look bruised or blistered
hives that do not itch
do not take more than directed
do not take at the same time as aluminum or magnesium antacids
do not take with fruit juices (see Directions)
an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children 12 years of age and over: take one 180 mg tablet with water every once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age: do not use
adults 65 years of age and older: ask a doctor
consumers with kidney disease: ask a doctor
safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.
| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-767-03 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51316-767-03 | EA - Each | 51316-767 | a5d975db-f829-43cd-9121-f38da0e66d5d | 1 | 2025-05-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51316-767 | 51316-767-03 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2019-10-18 | ||
| A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2019-10-18 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 74a2ff9319b5… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fexofenadine HCL | FEXOFENADINE HCL | CVS | 00ef8467-30a0-7579-e063-6294a90a75af | 2025-12-19 | Warnings | 51316-767-03 51316-767 51316076703 46540fb6-3247-8ddd-e063-6394a90ae0cb 00ef8467-30a0-7579-e063-6294a90a75af |
Adverse event summaries are temporarily unavailable. Other product information remains available.